13 results · 23ms · Sources: EU EUDAMED, US FDA

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PYTON

FDA 510(k)
FDA Class 2 ·Anesthesiology

SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CARIES DETECTOR

FDA 510(k)
FDA Class 2 ·Dental

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

VASOVIEW 6 ACCESSORY PACK

FDA Adverse Event
Malfunction ·MAQUET CV·Product code GCJ·January 10, 2019

Kit BD Max CT/GC/TV; Catalog # 442970

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011

PULSE GEN MODEL 103

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·May 3, 2013

HEARTSTART XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014

MLRY-HD LAT POR FMRL 11X160MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2019

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015